MyPrEP Plus: Development and Pilot Testing of Novel Preexposure Prophylaxis Decision Support Tool… (NCT07146139) | Clinical Trial Compass
TerminatedNot Applicable
MyPrEP Plus: Development and Pilot Testing of Novel Preexposure Prophylaxis Decision Support Tools for Transgender Women
Stopped: Recruitment was halted prematurely as a result of the termination of the grant by the NIH.
United States2 participantsStarted 2023-03-18
Plain-language summary
The primary goal of this randomized controlled trial is to learn if a decision support tool called MyPrEP Plus can help transgender women make decisions about taking pre-exposure prophylaxis (PrEP) for HIV prevention.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Are age 18 or older
* Identify as a transgender woman or woman and was assigned male sex at birth
* Are not currently on PrEP in the last three months and interested in learning more about PrEP
* Able to successfully send and receive text messages
* HIV negative by self-report
* Are able to speak, read and write in English or Spanish
* Report any of the following in the last 12 months:
* Having anal or vaginal sex with a person assigned male at birth
* Exchange of sex for money, goods, or services
* Received a diagnosis of a sexually transmitted infection
* Sharing injection equipment
* Are able and willing to provide written informed consent and participate for the duration of the study
Exclusion Criteria:
* In a mutually monogamous sexual relationship with an HIV-negative partner for the past 12 months
* Of any medical, psychiatric, or social condition that in the opinion of the investigator would preclude participation or their ability to remain in the trial
* Study site staff member
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility and acceptability of the MyPrEP Plus package for PrEP uptake in TGW as assessed by the Client Satisfaction Questionnaire, System Usability Scale, and intervention metrics.